<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260901070859N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-06</date_registration>
      <primary_sponsor>Vice President for Research, Semnan University</primary_sponsor>
      <public_title>Effects of a Sensory-Based Modified Tai Chi Program on Balance, Fear of Falling, and Quality of Life in Older Adults</public_title>
      <acronym></acronym>
      <scientific_title>Effects of a Sensory-Based Modified Tai Chi Program on Balance, Fear of Falling, and Quality of Life in Older Adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/92989</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study was a three-group, parallel-group, randomized trial with pretest, posttest, and 1-month follow-up assessments. The allocation sequence was created and implemented by randomization without blinding; the outcome assessors and the Tai Chi instructor were not blinded to the group allocation. No independent statistician was involved in the randomization or analysis. Unblinded allocation and lack of blinding are considered risk factors for bias in the limitations.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Old age.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Tai Chi exercise based on sensory diet will be performed for 8 weeks, three sessions per week, each session lasting 45-60 minutes. Intervention 2: Intervention group: Tai Chi exercise without sensory diet for 8 weeks, three sessions per week, each session lasting 45-60 minutes. Intervention 3: Control group: No intervention is performed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Reporting study findings in the form of published articles and presentations at relevant conferences and congresses

When:
Access period starts 6 months after results are published.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Reporting study findings in the form of published articles and presentations at relevant conferences and congresses

Where to obtain:
fatemeh rezaei frezaee39@gmail.com

How to obtain:
If the request is sent by the applicant, the email will be responded to within about a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Fatemeh Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Motor Behavior, Faculty of Humanities, Semnan University, First Campus, Opposite Sokan Park, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911135131</zip>
        <telephone>0098 23 3354086</telephone>
        <email>f_rezaee@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Motor Behavior, Faculty of Humanities, Semnan University, First Campus, Opposite Sokan Park, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911135131</zip>
        <telephone>0098 23 3354086</telephone>
        <email>f_rezaee@semnan.ac.ir</email>
        <affiliation>Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Absence of sensory and motor disabilities; having psychological health (score higher than 7 on the EMTS psychological test)
Ability to speak and understand Persian
Have not practiced Tai Chi recently.
Having full vision and hearing ability
No history of asthma, respiratory or cardiovascular disease
Not having any disabilities or using mobility aids such as canes and wheelchairs.
No serious injury to the skull
No history of anesthesia
Obtaining a score above 24 on the Mental State Assessment Questionnaire
Age range 60-75 years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patient's unwillingness to continue participating in the study
Absence of more than 2 sessions
Severe physical or mental problems
Death of an elderly person</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Age-related physical debility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Tai Chi exercise based on sensory diet will be performed for 8 weeks, three sessions per week, each session lasting 45-60 minutes.</i_keyword>
      <i_keyword>Intervention group: Tai Chi exercise without sensory diet for 8 weeks, three sessions per week, each session lasting 45-60 minutes.</i_keyword>
      <i_keyword>Control group: No intervention is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Before intervention; eight weeks after intervention initiation; one month after intervention completion. Method of measurement: Timed Up and Go test.</prim_outcome>
      <prim_outcome>Fear of falling. Timepoint: Before intervention; eight weeks after intervention initiation; one month after intervention completion. Method of measurement: Falls Efficacy Scale-International.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention; eight weeks after intervention initiation; one month after intervention completion. Method of measurement: Older People's Quality of Life Questionnaire (CASP-19).</prim_outcome>
      <prim_outcome>Static balance. Timepoint: Before intervention; eight weeks after intervention initiation; one month after intervention completion. Method of measurement: Sharpend Romberg test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice President for Research, Semnan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-25</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan, Basij Boulevard, Headquarters of Semnan University of Medical Sciences and Health Services, Semnan Province semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
